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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN45810007 |
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Date of registration:
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03/11/2009 |
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Primary sponsor: |
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Public title:
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Perioperative management of antiplatelet agents in general and visceral surgery: a pilot study
N/A |
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Scientific title:
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Pilot phase of a randomised controlled trial to optimise the perioperative management of antiplatelet agents in the field of general and visceral surgery |
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Date of first enrolment:
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Jan 1 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN45810007 |
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Study type:
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Interventional |
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Study design:
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Pilot two-armed block randomisation clinical controlled trial
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Countries of recruitment
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Germany
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Contacts
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Name:
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Juergen
Weitz |
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Address:
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Im Neuenheimer Feld 110
69120
Heidelberg
Germany |
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Telephone:
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+49 (0)6221 56 6110 |
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Email:
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juergen.weitz@med.uni-heidelberg.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Cardiac low and medium risk patients with antiplatelet agents
2. Informed consent
3. Aged over 18 years, either sex
4. Physical and psycological ability to participate in the trial
Exclusion criteria: 1. Cardiac high risk patients
2. Psychiatric disorder
3. No informed consent
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Surgical complication rates, thromboembolic events
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Intervention(s)
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In the pilot phase, we provide low-risk patients with acetylsalicylic acid (ASA) 100 mg/day. There are two arms of randomisation: discontinuation versus continuation of aspirin. Patients stop 5 days before operation and start on the 5th post-operative day again (if randomised to discontinuation) or continue the intake of aspirin. Follow-up is 30 days.
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Primary Outcome(s)
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1. Bleeding complications
2. Thromboembolic events
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Secondary Outcome(s)
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1. Duration of surgery
2. Blood loss during surgery
3. Complication rate
4. Length of hospital stay
5. Readmission to hospital after discharge
6. Difference between laparoscopic versus open surgery
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Secondary ID(s)
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S-003/2008
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Source(s) of Monetary Support
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University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) - Surgical Clinical Study Centre
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